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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0511-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-BP;   SOL: 0.9% SODIUM CHLORIDE IV FLUSH SYRINGE/PFF001;   HALYARD OWENS MINOR: 0.9% USP SODIUM CHLORIDE INJECTION/SS003, 0.9% USP SODIUM CHLORIDE INJECTION/SS005, 0.9% USP SODIUM CHLORIDE INJECTION/SS010, 10ML SYRINGE STERILE/SS010SFR",
  "description": "FDA recall Z-0511-2024 — Nurse Assist, LLC is recalling 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-BP;   SOL: 0.9% SODIUM CHLORIDE IV FLUSH SYRINGE/PFF001;   HALYARD OWENS MINOR: 0.9% USP SODIUM CHLORIDE INJECTION/SS003, 0.9% USP SODIUM CHLORIDE INJECTION/SS005, 0.9% USP SODIUM CHLORIDE INJECTION/SS010, 10ML SYRINGE STERILE/SS010SFR (Devices, Class I). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0511-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-BP;   SOL: 0.9% SODIUM CHLORIDE IV FLUSH SYRINGE/PFF001;   HALYARD OWENS MINOR: 0.9% USP SODIUM CHLORIDE INJECTION/SS003, 0.9% USP SODIUM CHLORIDE INJECTION/SS005, 0.9% USP SODIUM CHLORIDE INJECTION/SS010, 10ML SYRINGE STERILE/SS010SFR",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Nurse Assist, LLC"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0511-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0511-2024: Nurse Assist, LLC is recalling 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-BP;   SOL: 0.9% SODIUM CHLORIDE IV FLUSH SYRINGE/PFF001;   HALYARD OWENS MINOR: 0.9% USP SODIUM CHLORIDE INJECTION/SS003, 0.9% USP SODIUM CHLORIDE INJECTION/SS005, 0.9% USP SODIUM CHLORIDE INJECTION/SS010, 10ML SYRINGE STERILE/SS010SFR",
      "text": "The FDA logged enforcement record Z-0511-2024: Nurse Assist, LLC is voluntarily recalling 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-BP;   SOL: 0.9% SODIUM CHLORIDE IV FLUSH SYRINGE/PFF001;   HALYARD OWENS MINOR: 0.9% USP SODIUM CHLORIDE INJECTION/SS003, 0.9% USP SODIUM CHLORIDE INJECTION/SS005, 0.9% USP SODIUM CHLORIDE INJECTION/SS010, 10ML SYRINGE STERILE/SS010SFR — reason: Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-11-06. Affected lots/codes: Product Code/UDI-DI/Lot: 9210/20850020865042/21122520, 21122573, 22032938; 1203-BP/B1501203BP4/22022797; 1205-BP/B1501205BP4/22022789, 23024788; 1210-BP/B1501210BP4/21112359, 21112384, 21112388, 21112441, 21112451, 21122519, 21122550, 21122588, 21122614, 22012632, 22012669, 22012668, 22012672, 22012673, 22012677, 22012689, 21122572, 22012678, 22022824, 22012690, 22022827, 22022853, 22022857, 22032891, 22032923, 22032922, 22032935, 22032936, 22032937, 22032962, 22033016, 22032963, 22033026, 22033038, 22033061, 22033083, 22043095, 22043129, 22043135, 22043154, 22043172, 22043186, 22043210, 22043214, 22043227, 22043240, 22043253, 22053259, 22053270, 22053260, 22053282, 22053281, 22053293, 22053306, 22053333, 22053326, 22053341, 22053364, 22053382, 22063384, 22063411, 22063428, 22063416, 22063459, 22063481, 22063510, 22063523, 22063538, 22063554, 22073576, 22073596, 22073626, 22073668, 22073712, 22083756, 22083766, 22083798, 22083830, 22083894, 22083899, 22083917, 22093934, 22093951, 22093983, 22094015, 22094027, 22094057, 22094058, 22094076, 22094097, 22094121, 22104141, 22104149, 22104168, 22104182, 22104200, 22104226, 22104246, 22104278, 22114301, 22114328, 22114349, 22114366, 22114390, 22114413, 22114433, 22124485, 22124510, 22124529, 23014706, 23014528, 23014755, 23024867, 23045258, 23055569, 23065893, 23065922, 23086215, 23086351, 23096407; PFF001/20810062438895/23014656, 23014671; SS003/20885632389778/23035163, 23055622, 23086334; SS005/20885632389761/23035151, 23055649, 23076007, 23086323; SS010/20885632389754/23024926, 23035099, 23035143, 23045223, 23045305, 23055455, 23055658, 23065737, 23065794, 23065853, 23065958, 23065967, 23075984, 23076039, 23076086, 23076105, 23076121, 23086157, 23086189, 23086248, 23086264; SS010SFR/not distributed.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0511-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0511-2024&lang=eng"
        }
      },
      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0511-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0511-2024 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0511-2024&lang=eng",
        "value": "Class I",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0511-2024&lang=eng"
        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0511-2024/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
    }
  ],
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      "name": "FDA recall details — Z-0511-2024",
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0511-2024",
            "Status": "recorded"
          }
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Nurse Assist, LLC",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-11-06",
            "Status": "recorded"
          }
        },
        {
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Product Code/UDI-DI/Lot: 9210/20850020865042/21122520, 21122573, 22032938; 1203-BP/B1501203BP4/22022797; 1205-BP/B1501205BP4/22022789, 23024788; 1210-BP/B1501210BP4/21112359, 21112384, 21112388, 21112441, 21112451, 21122519, 21122550, 21122588, 21122614, 22012632, 22012669, 22012668, 22012672, 22012673, 22012677, 22012689, 21122572, 22012678, 22022824, 22012690, 22022827, 22022853, 22022857, 22032891, 22032923, 22032922, 22032935, 22032936, 22032937, 22032962, 22033016, 22032963, 22033026, 22033038, 22033061, 22033083, 22043095, 22043129, 22043135, 22043154, 22043172, 22043186, 22043210, 22043214, 22043227, 22043240, 22043253, 22053259, 22053270, 22053260, 22053282, 22053281, 22053293, 22053306, 22053333, 22053326, 22053341, 22053364, 22053382, 22063384, 22063411, 22063428, 22063416, 22063459, 22063481, 22063510, 22063523, 22063538, 22063554, 22073576, 22073596, 22073626, 22073668, 22073712, 22083756, 22083766, 22083798, 22083830, 22083894, 22083899, 22083917, 22093934, 22093951, 22093983, 22094015, 22094027, 22094057, 22094058, 22094076, 22094097, 22094121, 22104141, 22104149, 22104168, 22104182, 22104200, 22104226, 22104246, 22104278, 22114301, 22114328, 22114349, 22114366, 22114390, 22114413, 22114433, 22124485, 22124510, 22124529, 23014706, 23014528, 23014755, 23024867, 23045258, 23055569, 23065893, 23065922, 23086215, 23086351, 23096407; PFF001/20810062438895/23014656, 23014671; SS003/20885632389778/23035163, 23055622, 23086334; SS005/20885632389761/23035151, 23055649, 23076007, 23086323; SS010/20885632389754/23024926, 23035099, 23035143, 23045223, 23045305, 23055455, 23055658, 23065737, 23065794, 23065853, 23065958, 23065967, 23075984, 23076039, 23076086, 23076105, 23076121, 23086157, 23086189, 23086248, 23086264; SS010SFR/not distributed.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide Distribution: SC AZ, CA, FL, GA, HI, IA, IN, KS, KY, MA, ME, MN, MS, NC, ND, NE, NJ, NV, NY, OH, PA, RI, TX, WA, WI, AK, AL, AR, CO, CT, DC, ID, IL, LA, MD, MI, MO, MT, NH, NM, OK, OR, PR, SD, TN, UT, VA , WI, WV, WY.  OUS (foreign) distribution to: Canada",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}